Senate starts work on preparedness law reauthorization

May 18, 2011 (CIDRAP News) – A Senate committee began work on reauthorizing the Pandemic and All-Hazards Preparedness Act (PAHPA) yesterday by calling federal and public health officials before them to testify about gaps and what steps are needed to better prepare the nation against flu and bioterror threats.

The hearing took place before the Senate Committee on Health, Education, Labor, and Pensions, a group that includes two members who co-authored legislation to reauthorize PAHPA, Sen Richard Burr, R-N.C., and Sen Robert P Casey, Jr, D-Penn. Passed by Congress in 2006 against a backdrop of an H5N1 avian influenza pandemic threat, PAHPA was the law that established the Biodefense Advanced Research and Development Authority (BARDA) within the Department of Health and Human Services (HHS).

The legislation also breathed new life into Project BioShield, which was set up in 2004 to develop countermeasures against biological weapons and other threats. It also established a position within HHS to oversee the nation's preparedness actions, the assistant secretary for preparedness and response (ASPR). Nicole Lurie, MD, who currently holds the position, was among the group of public health experts who fielded legislators' questions yesterday.

During opening statements, Burr, who also authored the Senate version of the bill in 2006, said the committee needs to explore if any changes are needed to strengthen PAHPA in the reauthorization bill. "It's critical this committee take a hard look at what's working well and what's not working well," he said. "We've come a long way, but more work needs to be done."

He voiced concerns about budget cuts to preparedness programs in the tough financial climate and how the Obama administration prioritizes the nation's threats. Pointing out a list of public health emergencies, including the 2009 H1N1 pandemic, Haiti's cholera outbreak, the Gulf oil spill, and Japan's tsunami and nuclear disasters, Burr said lawmakers much ensure preparedness continuity.

Lurie told the committee that PAHPA provisions helped the nation respond to the 2009 H1N1 pandemic tested the nation's preparedness, and the law has led to more flexible and timely countermeasure deployment. She said the cooperative agreement element of the legislation has helped state public health systems become more resilient, which Lurie said she observed recently when visiting tornado disaster areas in southern states.

Some of the lawmakers questioned Lurie about the business climate for companies working to develop countermeasures, especially smaller ones, and if BARDA is communicating closely with the Department of Defense (DoD), the other federal agency that is actively involved in medical countermeasure development. She said the HHS has dramatically changed the way it manages countermeasure contracts to speed up the process and said BARDA officials have integrated DoD officials into their regular countermeasure portfolio reviews.

BARDA currently has 70 countermeasure projects that are in advanced development, which she said represents a dramatic increase from the zero it began with when PAHPA first went into effect, Lurie said.

A problem that hampers the addition of some new countermeasures to the nation's stockpile is a lack of regulatory science needed to evaluate new drugs and vaccines, Lurie said. Investments in regulatory science, such as developing good animal models to test new products, would speed the process, she added.

Legislators also raised concerns with Lurie about drug shortages and asked her to let them know if new ASPR authorities or federal agency changes might help alleviate gaps.

Burr wondered if the federal government needs a new threshold for countermeasures that are subject to emergency use authorizations. "A real threat is the inability to respond in a timely fashion," he said.

Casey asked Lurie what preparedness issues she worries most about. She said she is most concerned about threats the nation hasn't yet thought about and the status of state and local public health partners, who play a key role in assisting the federal response but are struggling in this difficult budget climate.

In other testimony, Robert Kadlec, MD, President George W. Bush's bioterrorism adviser who is currently with PRTM Management Consultants in Washington, DC, told legislators that he sees a stronger leadership role for the ASPR position, which was designed to use a military-type model to gather forces or resources in the event of an emergency. "We've made some half steps, but we're not there yet," he said.

In his written testimony, Kadlec suggested it would be helpful to Congress and private industry if HHS outlined its countermeasure priorities and intended procurements alongside its multiyear budgets. He also said BARDA's budget should provide for robust countermeasure development at a level that reflects their importance to the nation's security.

Phyllis Arthur, senior director of vaccines and diagnostics at the Biotechnology Industry Organization in Washington, DC, recommended that as lawmakers work on PAHPA reauthorization, they also reauthorize the Special Reserve Fund at a level that provides private industry the incentive to participate in medical countermeasure development.

In her written testimony, Arthur stated, "Congress should clearly articulate that development of medical countermeasures is a national security priority and that funding for these efforts be treated as national security and/or homeland security spending."

Michael Anderson, MD, associate chief medical officer at University Hospitals and a pediatrician at Rainbow Babies & Children's Hospital in Cleveland, urged legislators and federal officials to redouble their efforts to include children and other vulnerable groups in preparedness policies.

Emergency medical system and general hospital settings need to be well equipped to treat children in a national public health emergency, he said. "They're 25% of the population, and they're not little adults."

He pushed for lawmakers to set medical countermeasure goals for treating children that are on par with those for adults, and he recommended that pediatric medical surge capacity not be an afterthought during preparedness planning.

Susan Cooper, MSN, RN, commissioner of the Tennessee Department of Health, said that state public health officials work "where the rubber meets the road." She characterized the public health workforce as fragile and frayed, but said investments in public health are paying off. "Emergency preparedness is working well, but it's not an end point; it's a process."